Device recall
Z-1497-2023: CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It…
FDA device recall · Class II · Beaver Visitec International, Inc.
Key facts
| Recall number (Z-number) | Z-1497-2023 |
|---|---|
| Recall event | 91986 |
| Product | CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue by extreme cold to locally perform cryocoagulation on tissue. Ref: CT00.D01 |
| Product code | HPS |
| Recalling firm | Beaver Visitec International, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K202038 |
| FEI number | 1211998 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database